InspireMD, Inc. announced on June 24, 2025, that the U.S. Food and Drug Administration (FDA) granted Premarket Application (PMA) approval for its CGuard Prime Carotid Stent System in the United States. This approval is a pivotal milestone for the company, enabling its entry into the U.S. market.
The PMA approval is supported by best-in-class evidence from the C-GUARDIANS pivotal trial, which demonstrated the lowest 30-day (0.95%) and 1-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention. This robust clinical data validates the neuro-protective benefits of the MicroNet mesh technology.
CEO Marvin Slosman stated that CGuard Prime is positioned to redefine the treatment of carotid disease and stroke prevention, offering an important frontline, proven technology for U.S. patients. The approval also triggers the second of four milestone-driven warrant tranches from a May 2023 private placement, expected to provide $17.9 million in gross proceeds to support the imminent U.S. commercial launch.
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